1. Field of the Invention
The present invention refers to an apparatus and a method for quick acute and chronic pain suppression, particularly useful and effective towards high-grade pains and/or pains resistant to other analgesic drugs such as opiates.
2. Background of the Related Art
Pain therapy by electrostimulation is practiced with apparatuses normally producing wave trains ranging from 5 to 100 Hz, with variable duty cycle, at times implementing automatic frequency and amplitude scanning. These apparatuses are generally referred to as TENS when used in a non-invasive manner with surface electrodes, or as implanted electric stimulators when they are invasive. With reference to substantiated scientific literature, this kind of electroanalgesia works only with some types of pain, yet almost never or with largely unsatisfactory and unforeseeable results in high-grade chronic pain, neuropathic pain, pain non-responsive to morphine and/or derivatives thereof.
Moreover, these electric stimulations have a heuristic base of scientific and technological development; in fact, in the scientific literature, no commonly accepted explanation exists for the biological mechanisms of the analgesic effect that is produced in some cases. One of the theories, still erroneously considered as plausible to date, is that the electric stimulus fosters endorphin production, and endorphins, in turn, are accountable for the analgesia. Actually, targeted and published clinical research experimentally invalidated this explanation attempt, leaving this method to empiricism. More reliable is the explanation of operation according to Gate Control theory. Accordingly, these electric stimulations are deemed to have an inhibiting function on painful stimulus transmission, by blocking electric-type nerve conduction.
Ultimately, though using electronic technologies, the operation principle does not diverge much from the first attempts at electroanalgesia, historically ascribable to Hippocrates, who used torpedo fish to cure gout pains.
In preceding studies, the problem of oncological pain and that of high-grade chronic pain non-responsive to protocols have been specifically dealt with. These studies have led to the development of an “artificial neuron” able to generate “non-pain” information strings. The artificial bioinformation, by modulating suitable electric potentials carried into the nerve network by surface electrodes, overlaps pain-coding endogenous information, attaining a powerful analgesic effect.
Italian Patent No 1324899, to the same Inventor, begins to introduce the concepts of a so-called “Scrambler Therapy”, based on the concept of synthetic “non-pain” information for therapeutic purposes. The patent relates to the manufacture of an apparatus able to generate an “artificial neuron” allowing concrete use of this theoretical research and the subsequent technological development in clinical practice. Neuronal synthesis used in Italian Patent No 1324899 yielded waveform geometries quite similar to action potentials produced by human nerve cells (see FIG. 1), organized according to pre-programmed sequences that achieved a concrete result in terms of analgesic effect.
However, subsequent clinical testing of the neuronal synthesis used in Italian Patent No 1324899 exhibited some limitations, both in the method and in the hardware implementation of the apparatus, which entailed a less than satisfactory efficiency from the standpoint of reproducibility of clinical data, data that was operator-dependent, and in the difficulties encountered when treating more complex polyneuropathy cases, which appeared hardly manageable and rapidly recurring. Moreover, stimulation perception in some patients who were more sensitive, also due to neuropathic damage, was hardly tolerable. This compliance problem increased when treating particularly sensitive zones, such as the face, or specific regions of the body very rich in nerve terminations.
Synthesis was carried out by setting a string comprised of n action potentials of alike geometry, imitating that typical of nerve cells to which a control algorithm subtracted, in determined points, variable blocks of individual potentials, in order to create the required synthetic information in the form of strings. Such a procedure, initially being of a survey type, was mainly aimed at replacing the “pain” information with a bland nociception one; this to be sure to fall within information that the Central Nervous System (hereinafter, CNS) might easily recognize as “self”, therefore assessing with greater ease the exactness of the theoretical premise, reducing experimental variability.
This resulted in an extremely compressed dynamics of the putative “non-pain” synthetic information, as well as compressed was the ability to recruit polymodal receptors.